Drugs

Feds Settle with Purdue Pharma and Sackler Family

The Department of Justice says it has reached a global resolution of its criminal and civil investigations into the opioid manufacturer Purdue Pharma and a civil resolution of its civil investigation into individual company shareholders from the Sackler family. The agreements are subject to the approval of the federal bankruptcy court.

A department statement says Purdue will plead guilty in New Jersey federal court to a three-count felony information charging it with one count of dual-object conspiracy to defraud the United States and to violate the Federal Food, Drug, and Cosmetic Act, and two counts of conspiracy to violate the federal anti-kickback statute.

The department says the criminal resolution includes the largest penalties ever levied against a drug manufacturer, including a criminal fine of $3.544 billion and an additional $2 billion in criminal forfeiture. Purdue also agreed to a settlement of $2.8 billion to resolve its civil liability under the False Claims Act. The Sackler family separately agreed to pay $225 million in damages to resolve its False Claims Act liability.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome